The invention relates to a bone augmentation device. More particularly, the invention relates to a device for the attachment of soft tissues to bone by commonly used sutures.
Attachment of soft tissue to bone is a technique frequently required in orthopaedic surgical procedures. Bone augmentation devices are often used in repair of soft tissue avulsions from bone as well as in reconstructive procedures and in particular for the attachment of avulsed tendons, ligaments, and joint capsules to bone. For example, bone augmentation devices may be used to help correct shoulder instability, rotator cuff tears, knee instability, tenodesis and ligamentous repair of the foot, ankle, and wrist.
One known procedure for soft tissue attachment to bone is the classic Bankart procedure which is a widely accepted method of treating anterior-inferior glen-humeral instability of the shoulder and uses sutures that are inserted directly through transosseous tunnels. Although this procedure leads to excellent clinical results, the procedure of reattaching the torn ligament or tendon can be time consuming and difficult. While modifications that decrease the operating time for standard rotator cuff and Bankart lesion repair are available, these approaches are technically demanding.
Another known method for soft tissue attachment to bone is the use of surgical staples, however, staples have a tendency to cut through the bone and tendon and may be unstable or cause gapping between the soft tissue and the bone which can lead to poor healing.
There exists a need for a device that is simple to administer and effects a stable attachment of soft tissue to bone to facilitate healing.
The present invention is related to a bone augmentation device for attachment of soft tissue to bone by sutures. The device comprises a bone plate having a central plane and top and bottom surfaces spaced equidistant from the central plane with at least one hole extending between the top and bottom surfaces. The central plane includes a longitudinal axis and a horizontal axis. The plate is curved along the longitudinal and horizontal axes with a radius of curvature between 25 to 100 mm. The plate is made of a non-resorbable implant material.
In one preferred embodiment, the plate has a radius of curvature between 35 to 70 mm, and in another embodiment the plate has a radius of curvature between 45 to 55 mm.
In the preferred embodiment, the plate defines hole edges at the intersection of the through holes with the top and bottom surfaces and the hole edges are rounded with a radius of curvature between 0.2 to 0.8 mm. In another embodiment, the radius of curvature of the hole edges can be between 0.25 to 0.50 mm. In yet another embodiment, the radius of curvature of the hole edges is between 0.3 to 0.4 mm.
The plate defines outer edges along the periphery of the top and bottom surfaces and the outer edges are rounded with a radius of curvature between 0.2 to 0.7 mm. In another embodiment, the radius of curvature of the outer edges is between 0.30 to 0.50 mm. In yet another embodiment, the radius of curvature of the outer edges is between 0.35 to 0.45 mm.
The plate has a thickness defined between the top and bottom surfaces and in the preferred embodiment the thickness is less than 1 mm. In another embodiment, the thickness is less than 0.75 mm.
In the preferred embodiment, the top and bottom surface have a surface area between 100 to 250 mm2. In another embodiment, the top and bottom surface have a surface area between 125 to 175 mm.
In one embodiment, the plate has at least two through holes. In another embodiment, the plate has between 4 and 7 through holes.
In the preferred embodiment, the through holes have a diameter between 1.70 to 2.00 mm. In one embodiment, the through holes have a diameter between 1.80 to 1.90 mm. The through holes include a center and the distance between the centers in the preferred embodiment is between 3.0 to 4.3 mm. In other embodiments, the distance between the centers is between 3.4 to 3.8 mm.
In the preferred embodiment, the plate is made from titanium.